510(k) Report

Devices descending from K925548

273 later devices reach Fibracol Collagen-Alginate Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K090778Mta Protective SheetXylos Corporation20092—
+6K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+6K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+6K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+6K080353LTM-T Surgical MeshLifecell Corp.20084—
+6K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+6K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+6K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+6K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+7K260218LacertaMatrixLacerta Life Sciences20260—
+7K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+7K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+7K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+7K242187BioBrace®Conmed Corporation20241—
+7K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+7K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+7K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+7K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+7K211132ARISTE AB MeshAriste Medical, LLC20220—
+7K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+7K211972Omeza Collagen MatrixOmeza, LLC20210—
+7K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+7K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+7K180776Cytal Wound ParticulateAcell, Inc.20180—
+7K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+7K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+7K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+7K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+7K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+7K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+7K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+7K100984Xylos Vessel GuardXylos Corporation20100—
+7K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+7K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+7K083898SurgimendTei Biosciences, Inc.200993
+7K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+7K081327RelimeshHerniamesh S.R.L.20080—
+7K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+8K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+8K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+8K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+8K151083BioBridge Collagen MatrixFibralign Corporation20169—
+8K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+8K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+8K140501Xenmatrix Surgical GraftC. R. Bard20140—
+8K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+8K123128Seri Surgical ScaffoldAllergan20135—
+8K112567Biomerix AssureBiomerix Corporation20110—
+8K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+8K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+9K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+9K172545SERI ContourSofregen Medical, Inc.20170—
+9K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+9K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+9K140533Galaflex MeshTepha, Inc.20143—
+10K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+10K202425SurgiLattice scaffoldTepha, Inc.20210—
+10K162922GalaFORM 3DTepha, Inc.20170—
+10K161092GalaSHAPE 3DTepha, Inc.201611